Noon G P, Morley D, Irwin S, Abdelsayed S, Benkowski R, Lynch B E
Michael E. DeBakey Department of Surgery, Baylor College of Medicine, Houston, TX, USA.
Adv Card Surg. 2001;13:169-91.
After years of development and preclinical testing, clinical trials of the MicroMed DeBakey VAD began in November 1998 in Europe and in June 2000 in the United States. As of August 2000, 44 patients in Europe and 3 patients in the United States have undergone implantation with the MicroMed DeBakey VAD. In conclusion, data from the European clinical trial of the MicroMed DeBakey VAD support the safety and performance of the device. Results show that the device provides adequate left ventricular and circulatory support in patients with end-stage heart failure without unduly jeopardizing patient safety. Moreover, the device provides advantages not inherent to commercially available pulsatile devices: (1) miniature size, enabling implantation in smaller patients; (2) ease of implantation; (3) reduced surgical bleeding; and (4) a low incidence of postoperative infections, often a limiting factor with other devices. The MicroMed DeBakey VAD European clinical trial is the first demonstration of the compatibility of continuous blood flow with adequate tissue perfusion and overall maintenance of life for up to 4.5 months. This initial experience with the MicroMed DeBakey VAD suggests that the pump can provide circulatory support to bridge patients to cardiac transplantation and may provide an improved quality of life for the patient with end-stage heart failure.
经过多年的研发和临床前测试，MicroMed DeBakey心室辅助装置（VAD）于1998年11月在欧洲开始临床试验，并于2000年6月在美国开始临床试验。截至2000年8月，欧洲有44名患者和美国有3名患者接受了MicroMed DeBakey VAD植入手术。总之，MicroMed DeBakey VAD欧洲临床试验的数据支持了该装置的安全性和性能。结果表明，该装置可为终末期心力衰竭患者提供足够的左心室和循环支持，且不会过度危及患者安全。此外，该装置还具有市售搏动性装置所没有的优势：（1）尺寸小巧，能够植入体型较小的患者体内；（2）易于植入；（3）手术出血减少；（4）术后感染发生率低，而感染往往是其他装置的一个限制因素。MicroMed DeBakey VAD欧洲临床试验首次证明了持续血流与充足的组织灌注以及长达4.5个月的整体生命维持的兼容性。MicroMed DeBakey VAD的这一初步经验表明，该泵可为患者提供循环支持以过渡到心脏移植，并可能改善终末期心力衰竭患者的生活质量。
